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FDA Drug Application 050605 by GLAXOSMITHKLINE

Application Number	050605
Application Type	New Drug Application
Sponsor Applicant	GLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New ester, new salt, or other noncovalent derivative
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	12/28/1987	N
AP	8/19/1991	SLR
AP	8/19/1991	SLR
AP	3/13/1996	SE1
AP	1/31/1992	SE1
AP	8/19/1991	SLR
AP	1/27/1993	SLR
AP	8/9/1991	SCM
AP	1/27/1993	SLR
AP	1/31/1992	SCM
AP	10/18/1993	SLR
AP	6/28/1993	SCS
AP	12/19/1996	SE1
AP	6/30/1994	SLR
AP	8/30/1995	SCM
AP	12/23/1996	SLR
AP	9/13/1996	SLR
AP	9/13/1996	SLR
AP	12/6/1996	SE1
AP	9/17/1997	SE2
AP	12/23/1996	SLR
AP	6/4/1997	SLR
AP	11/19/1997	SCM
AP	1/16/1998	SCM
AP	3/24/1998	SLR
AP	3/29/2002	SLR	2334	031	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s31ltr.pdf	3/29/2002
AP	3/29/2002	SLR	2335	031	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s31lbl.pdf	3/29/2002
AP	8/24/1999	SE8	1388	032	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50605ltr.pdf	8/24/1999
AP	8/24/1999	SE8	1389	032	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50605S032_Ceftin.pdf	8/24/1999
AP	4/11/2002	SLR	2328	033	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s33ltr.pdf	4/11/2002
AP	4/11/2002	SLR	2329	033	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s33lbl.pdf	4/11/2002
AP	7/3/2001	SCM
AP	4/13/2001	SCS
AP	12/20/2001	SCM
AP	7/24/2002	SLR	2327	037	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605slr037ltr.pdf	7/24/2002
AP	6/3/2004	SLR	9075	039	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50605slr039,50672slr025ltr.pdf	6/7/2004
AP	6/3/2004	SLR	9134	039	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50605slr039,50672slr025_ceftin_lbl.pdf	6/7/2004
AP	7/23/2007	SLR	17360	042	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050605s042lbl.pdf	7/24/2007
AP	7/23/2007	SLR	17387	042	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050605s042ltr.pdf	7/27/2007
AP	9/20/2014	SLR	40544	043	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050605s043s046lbl.pdf	9/22/2014
AP	9/20/2014	SLR	40571	043	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050605Orig1s043,s046ltr.pdf	9/23/2014
AP	9/20/2014	SLR	40545	046	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050605s043s046lbl.pdf	9/22/2014
AP	9/20/2014	SLR	40572	046	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050605Orig1s043,s046ltr.pdf	9/23/2014
AP	6/26/2015	SLR	43179	047	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s047,050672s033lbl.pdf	7/1/2015
AP	6/26/2015	SLR	43260	047	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s047,050672Orig1s033ltr.pdf	7/7/2015
AP	8/26/2015	SLR	43737	048	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s048,050672s034lbl.pdf	8/27/2015
AP	8/26/2015	SLR	43740	048	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s048,050672Orig1s034ltr.pdf	8/28/2015

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